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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-1156

2. Registrant Information.

Registrant Reference Number: 070118989

Registrant Name (Full Legal Name no abbreviations): Wellmark International

Address: 100 Stone Road West, Suite 111

City: Guelph

Prov / State: Ontario

Country: Canada

Postal Code: N1G5L3

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

12-NOV-07

5. Location of incident.

Country: UNITED STATES

Prov / State: CONNECTICUT

6. Date incident was first observed.

18-OCT-07

Product Description

7. a) Provide the active ingredient and, if available, the registration number and product name (include all tank mixes). If the product is not registered provide a submission number.

Active(s)

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 2724-504

Product Name: Zodiac Spot On Plus Flea And Tick Control For Cats 5 lbs Over

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration 3.6 %
    • ETOFENPROX
      • Guarantee/concentration 40 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

1.8

Units: mL

10. Site pesticide was applied to (select all that apply).

Site: Animal / Usage sur un animal domestique

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

On October 17, 2007 the owner applied the product to her cat as a preventative measure.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

1.5

7. Weight (provide a range if necessary )

11

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>3 days <=1 wk / >3 jours <=1 sem

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Trembling
    • Symptom - Seizure
    • Symptom - Ataxia
  • General
    • Symptom - Death

12. How long did the symptoms last?

>24 hrs <=3 days / >24 h <=3 jours

13. Was medical treatment provided? Provide details in question 17.

Yes

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Died

16. How was the animal exposed?

Treatment / Traitement

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

On November 12, 2007 the APSS staff member stated that the signs the animal was displaying were consistent with an exposure to permethrin, rather than to cat product. The owner stated that the animal was taken into a local veterinary clinic where he received fluid therapy and seizure management. The animal died on October 20, 2007. The APSS veterinarian suggested that permethrin hair testing and a necropsy be performed on the animal. The owner declined further testing, stating that the animal was already buried.


To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here

The APSS veterinarian doubted this substance was related to the clinical situation. The owner stated that she does have a dog in the house and that it was possible she switched the cat product with the dog product. Signs are consistent with an exposure to a dog product containing permethrin.